An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 207569
Company: ANDA REPOSITORY

Products on ANDA 207569

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207569

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/2019	ORIG-1	Approval		STANDARD		Label is not available on this site.

Other OTC Drugs with the Same Active Ingredient, Strength and Dosage Form/Route

LORATADINE

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

TABLET;ORAL; 10MG

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	Application No.	Company
CLARITIN	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	Yes	019658	BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	Yes	019658	BAYER HEALTHCARE LLC
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	207569	ANDA REPOSITORY
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076471	APOTEX
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	208314	AUROBINDO PHARMA LTD
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	210722	GRANULES
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	211718	HETERO LABS LTD V
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	219223	MARKSANS PHARMA
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076154	MYLAN
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076301	PERRIGO
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	075209	PLD ACQUISITIONS LLC
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	076134	SUN PHARM INDS LTD
LORATADINE	LORATADINE	10MG	TABLET;ORAL	Over-the-counter	No	214684	UNIQUE PHARM

Top